Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 14, 2023
September 14, 2023
615429e8-d815-4bf4-bfc5-68955cba75bb
Related Documents
Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentSeptember 24, 2025Center for Devices and Radiological Health
Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentOctober 2, 2023Center for Devices and Radiological Health
Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJanuary 6, 2021Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox